Kornimate/medical-research-clean huggingface dataset:
study of hormonal sideeffects in patients taking levetiracetam, carbamazepine or lamotrigine for epilepsy

Conditions: Epilepsy

Summary: some antiepileptic drugs are found to have hormonal side effects. we want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. the participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.

we have previously performed long-term studies of rats treated with levetiracetam and compared them with a control group. here we have found that levetiracetam has a probable effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more corpora lutea and more secondary follicles than the untreated animals (taubøll et al 2004). blood tests on the animals showed that those treated with levetiracetam had higher testosterone levels and lower levels of estrogen and fsh, whilst lh and progesterone levels were unaffected by the treatment (svalheim et al, 2005a, b). studies on cell cultures from pig ovaries, as carried out by our group in collaboration with jagiellonian university, krakow, poland, appeared to support these findings (taubøll et al. 2006, submitted). our wish therefore now is to study fertile men and women in order to look for any changes in the balance of sex hormones during use of levetiracetam in order to establish whether the findings in animal trials are clinically relevant to humans.

Eligibility criteria:
inclusion criteria: * having epilepsy * age 18- 45 * using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months exclusion criteria: * hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease) * use of hormonal anticonception drugs or other hormonal drugs.
assessing impact in psoriatic treatment

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is a form of inflammatory arthritis associated with the skin condition psoriasis. a variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. very little is known about the decisions made to increase treatment in individual patients. previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice. this investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (psaid-12) questionnaire in the clinic setting can enable a better understanding of the impact of psa on each individual, improve physician-patient communication and lead to appropriate interventions. the psaid-12 questionnaire is a relatively new european developed questionnaire measuring patient impact across 12 different domains in psa. this study will use routine implementation of the psaid-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. the investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

this is an observational, cross-sectional study addressing the factors influencing treatment decisions in patients with psa. participants will be treated as usual in their routine clinical practice, but decisions on treatment will be recorded - whether treatment is escalated, unchanged or reduced, and why. the study will be conducted in 25 rheumatology centres in europe (uk, france, germany, spain and italy) with five centres in each country. each participant will only attend for one single study visit which is likely to last around 30 minutes in total. this will be alongside the participant's routine clinic visit. the psaid-12 questionnaire will be implemented on a tablet computer but the remaining outcomes will be collected on paper crfs and transferred to a database for analysis.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study and complete questionnaires in the local language. * aged 18 years or above. * diagnosed with psa according to the clasification of psoriatic arthritis (caspar) criteria and diagnosis confirmed by a rheumatologist (taylor 2006). exclusion criteria: * patients who don't speak or read the local language * patients who are not comfortable filling in an app-based questionnaire or paper crf. * patients with a new diagnosis of psa at the current clinic visit

Keywords: treatment decisions impact of disease
hyperoxia induced pulmonary inflammation and organ injury: a human in vivo model

Conditions: Oxygen Toxicity; Pulmonary Injury; Acute Lung Injury

Summary: oxygen is the most commonly administered therapy in critical illness. accumulating evidence suggests that patients often achieve supra-physiological levels of oxygenation in the critical care environment. furthermore, hyperoxia related complications following cardiac arrest, myocardial infarction and stroke have also been reported. the underlying mechanisms of hyperoxia mediated injury remain poorly understood and there are currently no human in vivo studies exploring the relationship between hyperoxia and direct pulmonary injury and inflammation as well as distant organ injury. the current trial is a mechanistic study designed to evaluate the effects of prolonged administration of high-flow oxygen (hyperoxia) on pulmonary and systemic inflammation. the study is a randomised, double-blind, placebo-controlled trial of high-flow nasal oxygen therapy versus matching placebo (synthetic medical air). we will also incorporate a model of acute lung injury induced by inhaled endotoxin (lps) in healthy human volunteers. healthy volunteers will undergo bronchoalveolar lavage (bal) at 6 hours post-intervention to enable measurement of pulmonary and systemic markers of inflammation, oxidative stress and cellular injury.


Eligibility criteria:
inclusion criteria: 1. healthy non-smoking subjects less than 45 years of age and bmi \< 29 kg/m² exclusion criteria: 1. age \< 18 years 2. on concomitant medications including over the counter medications excluding oral contraception and paracetamol 3. previous adverse reactions to lps, lignocaine or sedative agents 4. pregnant or breast-feeding 5. participation in a clinical trial of an investigational medicinal product within 30 days 6. consent declined 7. history of asthma or other respiratory conditions 8. smoking/ e cigarette use 9. marijuana use or other inhaled products with or without nicotine in the last 3 months 10. alcohol abuse, as defined by the alcohol use disorders identification test (audit) 11. subjects with history of prior conventional cigarette (\> 100 cigarettes lifetime and smoking within 6 months) or electronic cigarette use.
high dose chemotherapy with amifostine and autologous stem cell transplantation for high risk relapsed pediatric solid tumors and brain tumors

Conditions: Solid Tumors; Brain Tumors

Summary: this is a study of amifostine to determine how effective it is in the reduction of infection in a high dose chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

autologous stem cell transplant (asct) permits chemotherapy dose-escalation to exploit the steep dose-response of solid tumors to alkylating agents. although asct regimens have activity in some high risk pediatric solid tumors, non-hematological regimen-related morbidity and mortality are major barriers to additional dose escalation. we hypothesized that the chemoprotectant amifostine (ethyol®) would reduce the toxicity of asct without compromising anti-tumor efficacy. this is a study of amifostine at 1125 mg/m2 to determine the efficacy of it's chemoprotection in the reduction of bacteremia in a high dose busulfan, melphalan and thiotepa chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Eligibility criteria:
inclusion criteria: * high risk ewing's sarcoma family tumors (esft) including ewing's sarcoma, askin's tumor, peripheral pnet * high risk desmoplastic small round cell tumors (dsrct) * relapsed wilm's tumor, diffuse anaplastic wilm's tumor * high risk brain tumors including pnet/medulloblastomas/germinomas * relapsed germ cell tumors * metastatic or relapsed rhabdoid tumors * other relapsed/refractory pediatric embryonal tumors * less than 30 years of age * performance \>= 50% * cancer diagnosis verification and staging * disease response and recovery * adequate organ function (renal, liver, cardiac) exclusion criteria: * uncontrolled infection * pregnancy or breastfeeding (for females) * disease progression * uncontrolled intercurrent illness * hiv positive * receiving other investigational agents * amifostine allergy

Keywords: solid tumors brain tumors
steroid panel for one-step diagnosis of adrenal diseases

Conditions: Adrenal Disease

Summary: the aim of this study is to develop a one-step diagnostic method for adrenal diseases, patients with adrenal diseases including non-functioning adrenal adenoma, adrenal cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. using mass spectrometry analysis based on a multisteroid panel, serum, urine, saliva, and hair samples of the patients will be analyzed. the diagnostic yield of each and combination of steroids will be evaluated.

adrenal diseases consist of heterogenous diseases. to differentiate various adrenal diseases, multiple steps of diagnostic tests are needed. in this study, the investigators aimed to develop a one-step diagnostic method to differentiate various adrenal diseases using multisteroid panel. about 400 patients with adrenal diseases including non-functioning adenoma, adrenal cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. serum, hair, saliva, and urine samples of the patients will be analyzed using mass spectrometry. each and combination of multisteroid will be evaluated for diagnosing adrenal diseases.

Eligibility criteria:
inclusion criteria: * patients who are diagnosed with adrenal diseases exclusion criteria: * taking medications that can affect steroid metabolism * major depression, chronic alcoholism * suspected cancer metastasis to adrenal glands * other acute stress conditions
dose ranging study of brentuximab vedotin in adults with lupus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (sle).

systemic lupus erythematosus (sle) is a chronic, multisystem, disabling autoimmune condition, which predominantly affects women of childbearing years. treatment options for sle remain relatively limited. regardless of the specific therapy chosen, the majority of patients continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term morbidity and mortality. brentuximab vedotin is an antibody-drug conjugate (adc) consisting of: 1) the chimeric immunoglobulin (ig) g1 antibody cac10, specific for human cd30, 2) the microtubule disrupting agent monomethyl auristatin e (mmae), and 3) a protease-cleavable linker that covalently attaches mmae to cac10. since cd30 and/or cd30-expressing immune cells may play significant key roles in the pathogenesis of sle, brentuximab vedotin may be an efficacious therapy. this study intends to explore the potential for brentuximab vedotin as a therapy for sle.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years * diagnosis of sle for at least 6 months prior to screening * active sle as indicated by sle disease activity index (sledai) ≥ 4 at screening * must have failed a treatment for sle after a trial of at least 3 months exclusion criteria: * the subject has any serious health condition, which, in the opinion of the investigator, would place the subject at undue risk from the study * subject has had recent serious or ongoing infection, or risk for serious infection * subject has a history of new or recurrent malignancy within the past 5 years * the subject is pregnant and/or breastfeeding * the subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study * the subject has urgent, severe sle disease activity, which, in the opinion of the investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study

Keywords: lupus
anesthetic management of diabetes in perioperative urology and visceral surgery

Conditions: Diabetes Mellitus

Summary: it is recognized that a poor glycemic, pre- and intraoperative balance is the source of increase in morbimortality. there was no local protocol at the chru brest regarding the perioperative management of the diabetic patient. this retrospective observational work aims to assess the application of the french recommendations for the perioperative management of diabetes, and compare management before and after the introduction of a protocol based on its recommendations published in 2017 by the sfar. the main endpoint is the percentage of patients for whom half of the patients recommendations from the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after protocol and staff training.

half of the recommandations are implemented for each recommendation evaluated applicable in 29% of patients(n=25) in the before group versus 66.23% (n=52) in the after group (p\<0.05). this corresponds to an improvement significant of 36.23% for our primary endpoint.

Eligibility criteria:
inclusion criteria: * patients diabetics * urology or visceral surgery exclusion criteria: * ambulatory surgery

Keywords: diabetes glycemic balance anesthesia perioperative medecine
sedation and guided education for depression study

Conditions: Major Depressive Disorder (MDD)

Summary: the goal of this clinical trial is to understand how patient education surrounding a one-time, consciousness-altering medical intervention impacts the antidepressant response to the intervention in adults with major depressive disorder. in this study, the consciousness-altering medical intervention is a single infusion of propofol, an intravenous anesthetic which might have antidepressant properties. the main question this study aims to answer is: does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol? researchers will compare response-focused vs. diagnosis-focused education. qualifying participants will: * undergo a single intravenous infusion of propofol which will induce a temporary state of sedation * wear an eeg cap that records brain activity during sedation * be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation * be asked to fill out surveys about their mood and other measures of well-being before and after treatment


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder of at least moderate severity * able to read, understand, and provide written informed consent exclusion criteria: * pregnant or breastfeeding * certain substance use disorders * daily use of opioids and/or benzodiazepines * history of psychosis, schizophrenia, or schizoaffective disorder * body mass index greater than 35 kg/m2 * obstructive sleep apnea that is moderate and untreated, or severe * any gastrointestinal condition placing the patient at significant risk of aspiration

Keywords: propofol sedation patient education antidepressant major depressive disorder electroencephalography
personalised dose optimisation of zestril supported by the digital blood pressure diary in a primary care environment in england: pragmatic observational pilot study for remote hypertension treatment

Conditions: Uncomplicated Hypertension

Summary: a pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. by incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising zestril utilisation


Eligibility criteria:
inclusion criteria: 1. adults aged 18 years and older. 2. patients diagnosed with uncomplicated essential (primary) hypertension eligible for zestril per smpc for hypertension management. 3. participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures. 4. have access to and be able to use a suitable smartphone independently, running either ios version 15 or later or android version 10 or later. exclusion criteria: 1. clinically significant abnormal blood results as judged by the investigator (exclude patients with known renal impairment). 2. history of clinically important medical conditions that would compromise a patient's ability to participate safely (including an allergic reaction to zestril/lisinopril or any other medicine and/or other contraindications and interactions listed in zestril's smpc). 3. patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) as per smpc 4. participants who are unwilling or unable to participate in remote study procedures, including home bp monitoring, remote consultations, and data submission as judged by the investigator. 5. any condition associated with poor compliance including alcoholism or drug dependence. 6. participants with cognitive impairments or language barriers that hinder their ability to understand and comply with study instructions and e-questionnaires. 7. failure to satisfy the investigator of fitness to participate for any other reason.
effect of gender and hiv infection on zidovudine and lamivudine pharmacokinetics

Conditions: HIV

Summary: this study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without hiv infection. additionally, markers of side effects were correlated with blood levels of the drugs. the hypothesis was that women and those with hiv would have higher drug levels, as well as markers of side effects.


Eligibility criteria:
inclusion criteria: * documented physician-diagnosed hiv-infection (hiv+ antibody or plasma hiv-rna+); hiv-negative volunteers must have a negative hiv-elisa. * age 18 to 55 years; * either antiretroviral naïve, or no hiv-therapy in the preceding 6 months; * planned antiretroviral regimen includes standard doses of zdv plus 3tc as part of the antiretroviral regimen. once- or twice-daily 3tc will be allowed. exclusion criteria: * any medical condition that in the opinion of the investigators would jeopardize the intent of the study. * in the opinion of the investigator, any concomitant immunomodulatory medications, chemotherapeutic agents, investigational drugs, and alternative therapies, including, glucocorticoids, recombinant growth factors or cytokines (e.g. granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, interferon-alpha or gamma, human growth hormone, etc), ribavirin, birth-control pills, and sex hormones that could interfere with the cellular pharmacology of the study medications; * concomitant medications that interfere with renal drug clearances including, tenofovir, adefovir, cidofovir, ganciclovir, probenecid, or any similarly problematic medication in the opinion of the investigators; * concomitant warfarin or daily aspirin (to prevent excess bleeding from biopsy). * pregnancy or a plan to become pregnant, or menopause; * any \> or = grade ii abnormality in hemoglobin, absolute neutrophil count, routine liver function tests, serum creatinine, or other organ function abnormalities. * any medical or personal condition that, in the judgment of the investigators, may influence the subject's ability to comply with study conditions, such as active mental illnesses, or plans to leave the geographical area. * inability to give informed consent. * triple nucleoside analog reverse transcriptase regimens.

Keywords: pharmacokinetics antiretroviral therapy nucleoside analogs mitochondrial toxicity clinical pharmacology cellular pharmacology pharmacogenetics
tissue study on the chronic active humoral rejection (camr) population of kidney transplantation

Conditions: Kidney Transplant

Summary: the study is tissue-based, retrospective and prospective, single-centre, non-sponsored. primary objective: to examine patient and organ survival and egfr variation in kidney transplant patients diagnosed histologically with camr.

at the kidney transplant follow-up clinic of the uo nephrology, dialysis and transplantation unit of the irccs aoubo policlinico di sant'orsola, directed by prof. g. la manna, all patients with a diagnosis of camr made since 01/01/2018 and patients with a new diagnosis of camr made after the approval of this protocol by the ethics committee will be enrolled. the study will last 5 years and 6 months.

Eligibility criteria:
inclusion criteria: * age ≥18 years * kidney transplant recipients * egfr\>15 ml/min/1.73 sq m at the time of diagnosis of camr * camr diagnosis defined on the basis of the 2018 banff classification (17), made after 1/1/2018. * obtaining informed consent to participation. exclusion criteria: * combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas) * histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus bk nephropathy, other)